GMPs

Apr 04, 2018
By Pharmaceutical Technology Editors
A new book published in response to new USP chapters and ICH Q3D guidelines on measuring elemental impurities provides a practical guide for using plasma spectrochemistry for pharmaceutical analysis.
Apr 03, 2018
By Pharmaceutical Technology Editors
The company is recalling Pasta De Lassar Andromaco zinc oxide diaper rash treatment after FDA analysis confirmed the product contained high levels of yeast, mold, and bacteria.
Apr 03, 2018
Designing a mechanical integrity program using existing best practices can help pharmaceutical manufacturers comply with OSHA’s standard for process safety management.
Apr 02, 2018
Pharmaceutical Technology
Implementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.
Apr 02, 2018
Pharmaceutical Technology
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
Apr 02, 2018
Pharmaceutical Technology
Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Apr 02, 2018
By Pharmaceutical Technology Editors
Peter Stein, MD will present FDA’s keynote presentation at the CPhI North America conference on Thursday, April 26, 2018 in Philadelphia, PA.
Mar 23, 2018
By Pharmaceutical Technology Editors
The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.
Mar 20, 2018
By Pharmaceutical Technology Editors
The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.
Mar 20, 2018
By Pharmaceutical Technology Editors
The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.
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